SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

HILLS BALSAM EXTRA STRONG ‘2 IN 1’PASTILLES

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Pastille contains the following ingredients:

Active Ingredients	mg/pastille
Benzoin Tincture Compound BP	3.269
Ipecacuanha Liquid Extract BP	8.988
Menthol Ph Eur	19.897
Peppermint Oil Ph Eur	0.719

PHARMACEUTICAL FORM

Pastilles for oral administration

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

HILLS BALSAM EXTRA STRONG ‘2 IN 1’ PASTILLES are indicated for the symptomatic relief of coughs, colds and catarrh.

4.2 Posology and method of administration

Adults and the elderly:	One pastille to be dissolved in the mouth as required. No more than 10 pastilles in 24 hours.
Children over 12 years of age:	One pastille to be dissolved in the mouth as required. No more than 7 pastilles in 24 hours.
Children under 12 years of age:	Not recommended.

4.3    Contraindications

Patients who are known to be allergic to any of the constituents.

4.4    Special warnings and precautions for use

If symptoms persist or if you develop a wheezy chest, consult your doctor.

Patients should not exceed the recommended daily dose.

4.5 Interaction with other medicinal products and other forms of interaction

In vitro reports suggest that menthol may inhibits cytochrome P450 isoenzymes. Hence caution is advised when menthol containing products are concomitantly administered to patients taking therapeutic products.

4.6    Fertility, Pregnancy and lactation

There are no known human or animal data which suggest adverse effect with any of the ingredients of the product taken during pregnancy or lactation - but use with caution.

4.7    Effects on ability to drive and use machines

None

4.8 Undesirable effects

Allergic reactions are rarely reported. These include anaphylactic reactions, angioedema, and exacerbation of bronchial asthma.

4.9 Overdose

In the event of ingestion of large quantities of HILLS BALSAM EXTRA STRONG ‘2 IN 1’ PASTILLES, an emetic response would be provoked due to the ipecacuanha content of the formulation.

5.1 Pharmacodynamic properties

The product contains a number of well-established galenicals, all contributing to the overall effect of expectorant activity, symptomatic relief of bronchial and bronchitic conditions, reduction of bronchial catarrh, and local rubefacient action.

5.2 Pharmacokinetic properties

There is a local action by contact with the oro-pharynx, and by ‘inhalation’ through the nasal and oro-pharyngeal cavities.

5.3 Preclinical safety data

There are no preclinical data of relevant to the prescription of this product.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

HILLS BALSAM EXTRA STRONG ‘2 IN 1’ PASTILLES contain the following excipients:

granulated sugar, liquid glucose, modified starch, aniseed oil, capsicum oleoresin, annatto extract OF 323, natural red liquid OF 339, cough drop flavour PI 11292 NI, caster sugar and water.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 Years

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Heat sealed sachet of polypropylene/polyethylene/aluminium foil, integral with the carton. A metallised polypropylene/polyethylene laminate may be used as an alternative heat sealed sachet.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield

West Yorkshire WF2 7BJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 39974/0013

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2^nd February 2005

10 DATE OF REVISION OF THE TEXT

06/01/2012